Comparator sourcing involves comparing products. This can be to prove that a drug is more effective or works faster. “Most of the time, this is done for best in class, and is usually done during Phase II or III studies,” explained Lekishia White, vp at MultiPharma. “Comparative trials are prevalent, especially with increasing pressure to get the best drug on the market.”
There are risks involved with these studies. Most companies don’t want another company knowing that they are comparing their drug to another. However, said White, is it usually public domain since clinical trial information has to be revealed to the FDA. If the drug isn’t better, the company is still obligated to report the results.
“This is why drug development is so expensive. There is such a small percentage that makes it through the entire cycle. You could get through trials with a working therapy, but it may not be best in class so the company decides not to develop it.”
Some of the challenges involved in comparator outsourcing include obtaining all the appropriate paperwork and the import/export of materials. Companies have to obtain a certificate of analysis and/or an equivalency statement as well as approval to use materials. “There may be a drug registered and available in Europe, but not in the U.S. That would require an equivalency statement that ensures it’s the same formulation.”
Comparator-sourcing providers are specialized in terms of areas they service the most. “Some of us have better relationships with the innovator companies than others. It’s about relationship building.” White said the best way for a company in the industry to know which comparator-sourcing provider to use is to attend industry meetings and ask colleagues.
“The clinical trial circle of influence is quite small—word gets around quickly who is reliable and who is best.” This is a growing field, she added, with the number of providers doubling in the past two to three years. “There are at least ten comparative-sourcing providers—for such a small niche market, that’s a lot.”
There’s little doubt that CROs will continue to play a key role in the future of drug development. Most pharma and biotech companies will continue to maximize their R&D efforts. Knowing when to rely upon in-house capabilities and when to use a CRO remains crucial to whether a drug makes it to market. According to the Association of Clinical Research Organizations, biopharma outsources at least 30% of all clinical research. This figure will likely increase with demands.